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Volumn 22, Issue 2, 2003, Pages 239-264

Design and analysis of non-inferiority mortality trials in oncology

Author keywords

Active control trials; Non inferiority trials

Indexed keywords

CAPECITABINE; FLUOROURACIL; FOLINIC ACID; PLACEBO;

EID: 0037472909     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.1400     Document Type: Article
Times cited : (207)

References (16)
  • 1
    • 0034694856 scopus 로고    scopus 로고
    • Declaration of Helsinki. Ethical principles for medical research involving human subjects
    • World Medical Association
    • World Medical Association. Declaration of Helsinki. Ethical principles for medical research involving human subjects. Journal of the American Medical Association 2000; 284:3043-3045.
    • (2000) Journal of the American Medical Association , vol.284 , pp. 3043-3045
  • 2
    • 0000660099 scopus 로고    scopus 로고
    • E-10: Guidance on choice of control group in clinical trials
    • International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
    • International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). E-10: Guidance on choice of control group in clinical trials. Federal Register 64:51767-51780.
    • Federal Register , vol.64 , pp. 51767-51780
  • 3
    • 0034687072 scopus 로고    scopus 로고
    • Placebo controlled trials and active-control trials in the evaluation of new treatments. Part 1: Ethical and scientific issues
    • Temple R, Ellenberg SS. Placebo controlled trials and active-control trials in the evaluation of new treatments. Part 1: Ethical and scientific issues. Annals of Internal Medicine 2000; 133:455-463.
    • (2000) Annals of Internal Medicine , vol.133 , pp. 455-463
    • Temple, R.1    Ellenberg, S.S.2
  • 4
    • 0034687076 scopus 로고    scopus 로고
    • Placebo controlled trials and active-control trials in the evaluation of new treatments. Part 2: Practical issues and specific cases
    • Ellenberg SS, Temple R. Placebo controlled trials and active-control trials in the evaluation of new treatments. Part 2: Practical issues and specific cases. Annals of Internal Medicine 2000; 133:464-470.
    • (2000) Annals of Internal Medicine , vol.133 , pp. 464-470
    • Ellenberg, S.S.1    Temple, R.2
  • 6
    • 0033004225 scopus 로고    scopus 로고
    • Some issues in the design and analysis of equivalence trials
    • Hauck W, Anderson S. Some issues in the design and analysis of equivalence trials. Drug Information Journal 1999; 33:109-118.
    • (1999) Drug Information Journal , vol.33 , pp. 109-118
    • Hauck, W.1    Anderson, S.2
  • 7
    • 0032725063 scopus 로고    scopus 로고
    • Establishing equivalence by showing that a specified percentage of the effect of the active control over placebo is maintained
    • Holmgren EB. Establishing equivalence by showing that a specified percentage of the effect of the active control over placebo is maintained. Journal of Biopharmaceutical Statistics 1999; 9(4):651-659.
    • (1999) Journal of Biopharmaceutical Statistics , vol.9 , Issue.4 , pp. 651-659
    • Holmgren, E.B.1
  • 8
    • 0032968433 scopus 로고    scopus 로고
    • Bayesian design and analysis of active control clinical trials
    • Simon R. Bayesian design and analysis of active control clinical trials. Biometrics 1999; 55:484-487.
    • (1999) Biometrics , vol.55 , pp. 484-487
    • Simon, R.1
  • 9
    • 0032716231 scopus 로고    scopus 로고
    • Nonparametric analysis of covariance and its role in non-inferiority clinical trials
    • Koch GG, Tangen CM. Nonparametric analysis of covariance and its role in non-inferiority clinical trials. Drug Information Journal 1999; 33:1145-1159.
    • (1999) Drug Information Journal , vol.33 , pp. 1145-1159
    • Koch, G.G.1    Tangen, C.M.2
  • 10
    • 0035003536 scopus 로고    scopus 로고
    • Statistical methods for comparison to placebo in active-control trials
    • Hasselblad V, Kong DF. Statistical methods for comparison to placebo in active-control trials. Drug Information Journal 2001; 35:435-449.
    • (2001) Drug Information Journal , vol.35 , pp. 435-449
    • Hasselblad, V.1    Kong, D.F.2
  • 11
    • 0036169283 scopus 로고    scopus 로고
    • Choosing an equivalence limit for non-inferiority or equivalence studies
    • Wiens B. Choosing an equivalence limit for non-inferiority or equivalence studies. Controlled Clinical Trials 2002; 1-14.
    • (2002) Controlled Clinical Trials , pp. 1-14
    • Wiens, B.1
  • 12
    • 0032583387 scopus 로고    scopus 로고
    • Extracting summary statistics to perform meta-analyses of the published literature for survival endpoints
    • Parmar MKB, Torri V, Stewart L. Extracting summary statistics to perform meta-analyses of the published literature for survival endpoints. Statistics in Medicine 1998; 17:2815-2834.
    • (1998) Statistics in Medicine , vol.17 , pp. 2815-2834
    • Parmar, M.K.B.1    Torri, V.2    Stewart, L.3
  • 14
    • 12244291628 scopus 로고    scopus 로고
    • FDA Medical-Statistical review for Xeloda (NDA 20-896) dated 23 April
    • FDA Medical-Statistical review for Xeloda (NDA 20-896) dated 23 April, 2001.
    • (2001)
  • 15
    • 0003855105 scopus 로고
    • Counting Processes and Survival Analysis
    • Wiley: New York
    • Fleming TR, Harrington D. Counting Processes and Survival Analysis. Wiley: New York; 1991.
    • (1991)
    • Fleming, T.R.1    Harrington, D.2
  • 16
    • 0012897326 scopus 로고
    • Fieller's theorem
    • Kotz S, Johnson N (eds). Wiley: New York
    • Read CB. Fieller's theorem. In Encyclopedia of Statistical Sciences, Kotz S, Johnson N (eds). Wiley: New York, 1983; 86-88.
    • (1983) Encyclopedia of Statistical Sciences , pp. 86-88
    • Read, C.B.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.